Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer (ELCCA-II)
Primary Purpose
Breast Cancer, Melanoma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
quality of life assessment
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- diagnosis of cancer (breast or melanoma) since less than 1 month
- no metastasis
- Inform Consent Form signed
Exclusion Criteria:
- severe psychiatric disorder (depression, psychosis, etc.)
- addictive pathology
- longtime antidepressant treatment (> 3 months)
- Patient pregnant or breastfeeding
Sites / Locations
- ICO René Gauducheau
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cancer quality of life
Arm Description
All patients with breath cancer or melanoma will have quality of life assessment 1, 6, 12, 24, 48 and 60 months after the initial cancer diagnosis
Outcomes
Primary Outcome Measures
long term evolution of quality of life for patient with breast cancer or melanoma
The evolution of quality of life will be assess with standardized quality of life questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT02893774
First Posted
August 25, 2016
Last Updated
July 31, 2023
Sponsor
Institut Cancerologie de l'Ouest
1. Study Identification
Unique Protocol Identification Number
NCT02893774
Brief Title
Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer
Acronym
ELCCA-II
Official Title
Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 12, 2015 (Actual)
Primary Completion Date
February 20, 2023 (Actual)
Study Completion Date
February 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Generally, French studies concerned with the quality of life of cancer patients focus on the period of treatment (up to 2 years post diagnosis). However, studies about quality of life "after" cancer are relatively rare (= long-term quality of life, or from 5 years post diagnosis). These studies mainly concern the most common cancers (breast and prostate).
Or changes in quality of life after treatment could be different depending on the type of cancer. In addition, there is a significant influence of sociodemographic variables on the quality of life in remission.
Similarly using remote diagnostics, quality of life questionnaires related to health, must be reassessed because too often developed for situations in process.
Based on these findings, "ELCCA II" study proposes to study for five years, the evolution of the impacts of two types of cancer (breast and melanoma) on quality of life (overall and related to the subjective health), socioeconomic status, and behavioral and emotional dimensions (post-traumatic development, coping, anxiety-depression) of those treated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Melanoma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
314 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cancer quality of life
Arm Type
Experimental
Arm Description
All patients with breath cancer or melanoma will have quality of life assessment 1, 6, 12, 24, 48 and 60 months after the initial cancer diagnosis
Intervention Type
Other
Intervention Name(s)
quality of life assessment
Intervention Description
All patients with breath cancer or melanoma will have quality of life assessment 1, 6, 12, 24, 48 and 60 months after the initial cancer diagnosis.
Those assessment will use standardized quality of life questionnaire :
QLQ-C30
SWLS (Satisfaction with Life Scale)
PTGI (Post-Traumatic Growth Inventory)
HADS (Hospital Anxiety and Depression Scale)
Brief COPE
MHLCS (Multidimensional Health Locus of Control Scale)
Primary Outcome Measure Information:
Title
long term evolution of quality of life for patient with breast cancer or melanoma
Description
The evolution of quality of life will be assess with standardized quality of life questionnaire
Time Frame
5 years after initial cancer diagnostics
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of cancer (breast or melanoma) since less than 1 month
no metastasis
Inform Consent Form signed
Exclusion Criteria:
severe psychiatric disorder (depression, psychosis, etc.)
addictive pathology
longtime antidepressant treatment (> 3 months)
Patient pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CAMPONE Mario, Pr
Organizational Affiliation
Institut de Cancérologie de l'Ouest
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICO René Gauducheau
City
Nantes
ZIP/Postal Code
44805
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer
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